ECRON ACUNOVA
 
 
 
 

‘What should the New Indian Govt. do in Clinical Research' by D A Prasanna, Chairman ACRO India

 
The regulatory framework on clinical trials needs a coherent set of stand-alone rules. This will not only ensure adherence to the principles laid down by the Supreme Court but also give impetus to the clinical trials industry in India, currently languishing due to an uncertain regulatory environment.

In recent months, the quest for a safer, more transparent clinical trials regime has found new momentum. Fourteen notifications in July 2014, governing various aspects pertaining to a clinical trial — ranging from placebo-controlled trials to compensation awards — have been notified. Further, the Central Drugs Standard Control Organization (CDSCO) has proposed a forward-looking IT-enabled information system that will ensure transparency and protect the interests of trial subjects.

These developments are important steps for the clinical trials regime in India to satisfy the three principles laid down by the Supreme Court for approving trials — assessment of risk versus benefit to patients, need for innovation vis-à-vis existing therapeutic option and the unmet medical needs in the country. But for satisfying these standards, much more remains to be done. The entire regulatory framework pertaining to clinical trials needs to be overhauled and a clear, coherent and succinct set of stand-alone rules needs to be introduced for this purpose. This will not only ensure adherence to the principles laid down by the Supreme Court but also give impetus to the clinical trials industry in India, currently languishing due to an uncertain regulatory environment.
 
 
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